WO2012132286A1 - Aiguille pour la perfusion de médicament et procédé de perfusion de médicament - Google Patents

Aiguille pour la perfusion de médicament et procédé de perfusion de médicament Download PDF

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Publication number
WO2012132286A1
WO2012132286A1 PCT/JP2012/001783 JP2012001783W WO2012132286A1 WO 2012132286 A1 WO2012132286 A1 WO 2012132286A1 JP 2012001783 W JP2012001783 W JP 2012001783W WO 2012132286 A1 WO2012132286 A1 WO 2012132286A1
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WO
WIPO (PCT)
Prior art keywords
needle
medicine
drug
container
vent
Prior art date
Application number
PCT/JP2012/001783
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English (en)
Japanese (ja)
Inventor
朗 ▲樋▼口
晃庸 奥田
章博 太田
結輝 竹中
中村　徹
Original Assignee
パナソニック株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by パナソニック株式会社 filed Critical パナソニック株式会社
Priority to US14/008,808 priority Critical patent/US9254243B2/en
Priority to CN2012800163737A priority patent/CN103458853A/zh
Priority to EP12764555.4A priority patent/EP2692325A1/fr
Priority to JP2013507139A priority patent/JP5723970B2/ja
Publication of WO2012132286A1 publication Critical patent/WO2012132286A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube

Definitions

  • the present invention relates to a method for transferring a medicine such as an injection filled in a container in a medical field. Specifically, the present invention relates to a drug transfer needle and a drug transfer method used when a drug is aspirated or discharged by a syringe.
  • the pumping operation is an operation in which suction is started from a state where an air layer smaller than the volume of the medicine to be sucked is previously stored in the syringe, and the plunger of the syringe is pushed and pulled many times.
  • the medicine in the medicine container is gradually replaced with air.
  • the pumping operation is time-consuming and labor-intensive for an operator such as a pharmacist. Further, when the viscosity of the medicine in the medicine container is high, the viscosity resistance when the medicine passes through the injection needle becomes high, so that the operator needs a large force.
  • the suction operation from the drug container to the syringe requires time and labor for the operator and is a heavy work burden.
  • the gas in the medicine container is first aspirated slightly, and the liquid in the syringe and the gas in the medicine container are gradually replaced.
  • this work places a heavy work burden on the operator.
  • FIG. 11 is a partial cross-sectional view of a conventional medicine transfer needle 1.
  • a metal needle 2 and a needle base 3 are integrated.
  • the medicine transfer needle 1 is configured by partially fitting the outer cylinder 4 on the outside of the metal needle 2 and forming an air vent groove 4 a between the metal needle 2 and the outer cylinder 4.
  • the drug transfer needle 1 has a configuration in which a filter 6 made of a hydrophobic synthetic resin is attached in the vicinity of the air vent 4b at one end of the air vent groove 4a.
  • the bubbled air 5a enters the drug container 8 from the air vent groove 4a of the drug transfer needle 1 so that the pressure difference is eliminated, and the pressure of the gas 10 in the drug container 8 is atmospheric pressure. Is almost the same.
  • the pressure of the gas 10 in the medicine container 8 is adjusted to be substantially equal to the atmospheric pressure. This eliminates the need for the pop-up operation of the syringe 7 and reduces the work burden when sucking the drug from the drug container 8.
  • the conventional drug transfer needle 1 when the drug transfer needle 1 is extracted from the rubber stopper of the drug container 8, the drug 9 is ejected in a mist form from the puncture mark of the rubber stopper of the drug container 8. May be generated.
  • the operator In order to prevent the generation of aerosol, it is necessary for the operator to pull out the metal needle 2 in a state where the gas 10 in the drug container 8 is set to a negative pressure that is lower than the atmospheric pressure.
  • the opening of the air vent groove 4a is opened from the inside of the medicine container 8 to the outside in a state where the liquid passage port of the metal needle 2 is kept inside the medicine container 8. It is possible to move it to When the medicine transfer needle 1 is pulled out from the medicine container 8 in this manner, negative pressure adjustment processing for reducing the pressure of the gas 10 in the medicine container 8 can be performed.
  • the drug 9 does not leak from the inside of the drug container 8 when the drug transfer needle 1 is pulled out from the rubber stopper of the drug container 8.
  • the outer diameter of the outer cylinder 4 is larger than the outer diameter of the metal needle 2. For this reason, even if an elastic recovery force such as butyl rubber forming the rubber plug is generated, the hole opened in the rubber plug by insertion of the outer cylinder 4 of the medicine transfer needle 1 has a gap between the hole and the metal needle 2. It is thought that it may occur. In this case, the drug 9 may leak out from a part of the hole of the rubber stopper of the drug container 8. Further, when adjusting the negative pressure, there is a possibility that outside air may enter into the medicine container 8 as air bubbles from the gap between the rubber plugs and the negative pressure cannot be adjusted sufficiently.
  • the present invention solves these problems, and an object thereof is to provide a drug infusion needle and a drug infusion method that can be handled safely and have a low work load.
  • the drug transfer needle of the present invention comprises a needle base attached to a syringe tip, a cylindrical part adjacent to the needle base, and a cylindrical part that is covered with the cylindrical part and has one end and the other end
  • the first needle part having an air passage that is exposed to the outside from the cylindrical part
  • the second needle part that is covered with the cylindrical part and has a liquid passage inside.
  • the second needle part is longer than the first needle part, and the axial direction of the first needle part and the axial direction of the second needle part are parallel, A portion constituted by the second needle portion having a liquid passage opening of the liquid passage is used as a tip portion, and a portion arranged adjacent to the tip portion and constituted by the tube portion and the second needle portion
  • the base portion is a portion that is disposed adjacent to the intermediate portion and is configured by the cylindrical portion, the second needle portion, and the first needle portion
  • the diameter of the intermediate part is larger than the diameter of the tip part, and the diameter of the intermediate part is smaller than the diameter of the base part.
  • the medicine infusion needle attached to the syringe is inserted into the medicine container with the liquid passage opening and the first ventilation opening, and the second ventilation opening is provided outside. Inserted into the drug container while remaining in the Move the plunger of the syringe to suck or discharge the drug in the drug container or the syringe, The first vent is disposed outside the medicine container while leaving the liquid passage opening in the medicine container, and after pulling the plunger to make the gas pressure in the medicine container negative, the medicine container Further, the second needle portion is extracted.
  • the present invention when the drug transfer needle is pulled out from the rubber stopper of the drug container, sufficient negative pressure adjustment processing is possible, and the drug does not leak out. Therefore, the present invention can provide a medicine infusion needle and a medicine infusion method that can safely handle medicine and have a low work load.
  • FIG. 1 is a perspective view showing a schematic configuration of a drug transfer needle according to a first embodiment of the present invention
  • FIG. 2 is a cross-sectional view showing the arrangement of a drug infusion needle and a drug container when performing negative pressure adjustment processing in the first embodiment of the present invention
  • FIG. 3 is a partial cross-sectional view of a drug transfer needle and a drug container according to the first embodiment of the present invention
  • FIG. 4 is a top view of the drug infusion needle according to the first embodiment of the present invention
  • FIG. 5A is a front view showing an external structure of a drug transfer needle according to the first embodiment of the present invention
  • FIG. 5B is a cross-sectional view of the drug infusion needle according to the first embodiment of the present invention as seen from the cutting line 7B-7B in FIG. 5A;
  • FIG. 5C is a cross-sectional view of the drug infusion needle according to the first embodiment of the present invention, as seen from the cutting line 7C-7C in FIG. 5A.
  • FIG. 6 is a flowchart of a drug infusion method using the drug infusion needle according to the first embodiment of the present invention.
  • FIG. 7 is a cross-sectional view of a drug transfer needle and a drug container showing a state in which a suction operation is performed using the drug transfer needle according to the first embodiment, FIG.
  • FIG. 8 shows the state of the drug transfer needle and the drug container in a state where the rubber stopper is elastically deformed when the negative pressure adjustment process in the drug container is performed using the drug transfer needle according to the first embodiment of the present invention. It is a partial sectional view, FIG. 9 is a partial cross-sectional view of a drug transfer needle and a drug container showing a state where the rubber stopper is elastically deformed when performing negative pressure processing using another drug transfer needle, FIG. 10 is a front view illustrating a schematic configuration of a mixing unit in the drug mixing device according to the second embodiment of the present invention; FIG. 11 is a partial cross-sectional view of a conventional medicine transfer needle.
  • FIG. 1 is a perspective view showing a schematic configuration of a medicine transfer needle 20 according to the first embodiment of the present invention.
  • FIG. 2 is a cross-sectional view showing the arrangement of the drug transfer needle 20 and the drug container (vial bottle) 25 when performing negative pressure adjustment processing in the drug container in the first embodiment of the present invention.
  • the medicine transfer needle 20 of the first embodiment includes a metal needle 11 and a needle cover 12.
  • the metal needle 11 is an example of a center needle.
  • the needle cover 12 is composed of a cylindrical needle base portion 12a, a cylindrical portion 13, and a first needle portion 14, as shown by a dotted line in FIG.
  • the center axis of the needle base portion 12 a, the tube portion 13, and the first needle portion 14 is arranged along the axial direction of the needle cover 12.
  • the cylindrical needle base 12 a is attached to the tube tip 22 of the syringe 21.
  • the tube portion 13 is disposed adjacent to the side opposite to the syringe side of the needle base portion 12 a and covers the metal needle 11 and the first needle portion 14.
  • the first needle portion 14 has a proximal end disposed adjacent to the side opposite to the syringe side of the needle base portion 12a and is disposed adjacent to and parallel to the cylindrical portion 13, and the distal end is inclined.
  • the 1st needle part 14 has the ventilation path 14a extended along the axial direction of the 1st needle part 14 in the inside.
  • One end (tip) of the air passage 14 a forms a first air vent 14 b that is opened obliquely near the middle portion of the tube portion 13.
  • the other end (base end) of the ventilation path 14a forms a second ventilation port 18 surrounded by the cylindrical portion 18a at a position adjacent to the needle base 12a.
  • the second ventilation opening 18 opens outward in a direction (for example, a direction orthogonal to the direction) intersecting the axial direction of the ventilation path 14a.
  • a filter 17 is fitted and attached in the cylindrical portion 18a so that dust and the like do not enter the air passage 14a. Therefore, in the 1st needle part 14 of the needle cover 12, the 1st ventilation hole 14b which is one end of the ventilation path 14a is arrange
  • the metal needle 11 is composed of a second needle portion 15.
  • the second needle portion 15 has an axial direction 15 f disposed in parallel with the axial direction of the first needle portion 14.
  • the second needle portion 15 is longer than the first needle portion 14.
  • the second needle portion 15 has a liquid passage 15 a extending along the axial direction 15 f inside thereof, and the tip (tip portion 11 e side) is exposed from the cylindrical portion 13.
  • the first needle portion 14 is disposed adjacent to the syringe side of the second needle portion 15.
  • one end (base end) 15d of the liquid passage 15a is connected to a cavity 12b inside the needle base portion 12a.
  • the other end (tip) of the fluid passage 15a is opened outward in a direction (for example, a direction orthogonal to the direction) intersecting the axial direction of the fluid passage 15a to form a fluid passage 15b.
  • the liquid passage 15a and the air passage 14a do not communicate with each other and are formed independently.
  • the medicine transfer needle 20 includes a tapered tip portion 16a, a cylindrical intermediate portion 16b adjacent to the tip portion 16a, a portion adjacent to the intermediate portion 16b, and a portion on the tip side is a cone.
  • the remaining part of the shape has a substantially cylindrical base 16c.
  • the distal end portion 16a is composed of a second needle portion 15 having a liquid passage port 15b.
  • the intermediate part 16 b is composed of the second needle part 15 and the cylinder part 13.
  • the base portion 16 c includes the second needle portion 15, the tube portion 13, and the first needle portion 14.
  • the medicine transfer needle 20 is covered with a needle cover 12 except for the distal end portion 16a.
  • the diameter d2 of the intermediate part 16b is larger than the maximum diameter d1 of the tip part 16a. Further, the diameter d2 of the intermediate portion 16b is smaller than the maximum diameter d3 of the base portion 16c. Furthermore, in the first embodiment, the relationship between the maximum diameter d1 of the distal end portion 16a, the diameter d2 of the intermediate portion 16b, and the maximum diameter d3 of the base portion 16c is 1 ⁇ d2 / d1 ⁇ 1.9 and 1 ⁇ d3 / d1 ⁇ 1.9. The upper limit value of 1.9 and the lower limit value of 1 in these relationships are obtained by the inventors through experiments in order to achieve the following desired effects.
  • the medicine transfer needle 20 can be smoothly inserted into or removed from the rubber stopper 26 of the medicine container 25, and leakage of the medicine 27 or intrusion of air bubbles can be prevented.
  • the metal needle 11 is a needle formed of a metal such as stainless steel.
  • the needle cover 12 is a cover formed of synthetic resin such as PE resin or ABS resin. When formed of such a material, the drug transfer needle 20 can be created by, for example, insert molding. Specifically, the needle cover 12 can be formed by excluding the tip and wrapping the metal needle 11 with a molten resin and then solidifying the molten resin.
  • medical agent injection needle 20 in 1st Embodiment is taken as the structure comprised with a metal needle and a resin body, it does not necessarily need to be comprised in that way.
  • all of the medicine transfer needle 20 may be made of a resin body such as PE resin or ABS resin.
  • the drug container 25 used in the first embodiment has a transparent bottle 28 and a rubber plug 26 that covers the mouth of the bottle 28 as shown in FIG.
  • FIG. 3 is a partial cross-sectional view of the drug transfer needle 20 and the drug container 25 according to the first embodiment of the present invention.
  • the medicine transfer needle 20 of the first embodiment is provided with a distance L1 along the axial direction 15f.
  • the interval L1 is between the liquid passing port 15b of the second needle part 15 and the intermediate part 16b, more specifically, between the proximal end side edge of the liquid passing port 15b of the second needle part 15 and the distal end side of the intermediate part 16b. It is provided between the edges.
  • the medicine transfer needle 20 is provided with an interval L2 along the axial direction 15f of the first vent 14b along the axial direction 15f.
  • the medicine transfer needle 20 is provided with an interval L3 along the axial direction 15f.
  • the interval L3 is provided between the first ventilation port 14b and the liquid passage port 15b, more specifically, between the edge on the distal end side of the first ventilation port 14b and the edge on the proximal end side of the liquid passage port 15b. ing.
  • the interval L3 is set to 3 mm or more so as to be equal to or greater than the thickness of a rubber stopper of a general medicine container. Further, from the viewpoint of more surely preventing the air bubbles supplied from the first vent 14b from being sucked through the liquid vent 15b, the interval L3 is preferably set to 10 mm or more. In addition, since the length of the needle portion of a commonly used injection needle is 40 mm or less, considering the cooperation with other tools, the distance L3 is set to 40 mm or less, and the needle portion is stored in a general injection needle storage case. To be able to.
  • the distance L3 can be set to 7 mm or more and 40 mm or less.
  • the thickness of the central portion 26a for piercing the drug transfer needle 20 is a rubber plug 26 having a thickness of 7 mm or less, as shown in FIG.
  • a rubber plug 26 can be interposed between the two and 14b. That is, since the wall thickness of the central portion 26a of the general-purpose rubber plug 26 is 3 mm to 7 mm, the distance L3 between the end edge on the distal end side of the first vent port 14b and the end edge on the proximal end side of the liquid flow port 15b. If it is 7 mm or more, as shown in FIG. 2, the center part 26a of the rubber plug 26 can be interposed between the liquid flow port 15b and the first vent port 14b.
  • the rubber plug is provided between the liquid inlet 15b and the first vent 14b. 26 can be reliably interposed, and the rubber plug 26 can be in close contact with the second needle portion 15 to seal the drug container 25.
  • the medicine transfer needle 20 of the first embodiment enables negative pressure processing, it can be safely removed from the medicine container 25 after the suction work, and the suction work can be efficiently performed. It is a possible configuration.
  • the interval L1 between the proximal end edge of the liquid passing port 15b of the second needle section 15 and the distal end edge of the intermediate section 16b is set to 3 mm or less. Yes.
  • L1 ⁇ 3 mm is set in order to securely seal the drug container 25 in consideration of the elastic deformation of the rubber stopper 26 when the drug transfer needle 20 is pulled out. Details of this will be described later.
  • the interval L2 along the axial direction 15f of the first vent port 14b is set to 0.1 mm or more and less than 3 mm, and the interval is larger than the thickness of the rubber plug of a general drug container.
  • L2 is shortened. In this way, by setting L2 ⁇ 3 mm, for example, when the first vent 14b is pulled out from the drug container 25, the inside and outside of the drug container 25 communicate with each other through the first vent 14b, and the drug 27 goes to the outside. Leakage can be prevented.
  • the reason why the distance L2 is set to 0.1 mm or more is to provide the first vent 14b with an inclination.
  • the first needle portion 14 of the drug transfer needle 20 in the first embodiment has an inclination angle ⁇ as shown in FIG.
  • This inclination angle ⁇ is an inclination angle of the tip of the first needle part 14 with respect to the axial direction 15f of the second needle part 15.
  • the inclination angle ⁇ is set to be 12.5 ° or more and 20.5 ° or less on the side where the first vent 14b is formed. In this way, by setting 12.5 ° ⁇ ⁇ ⁇ 20.5 °, the air bubbles generated from the first vent 14b move in the direction away from the second needle portion 15. Therefore, by configuring the inclination angle ⁇ in this way, it is possible to reduce the possibility of air bubbles being caught in the liquid passage port 15b.
  • FIG. 4 is a top view of the drug infusion needle 20 according to the first embodiment of the present invention.
  • the medicine transfer needle 20 prevents suction of air bubbles generated from the first vent 14b through the liquid inlet 15b during the suction operation of the medicine 27 in the medicine container 25 described later.
  • the cross section of the medicine transfer needle 20 (surface perpendicular to the axial direction of the needle) is devised. Specifically, in the cross section (surface perpendicular to the axial direction of the first needle part 14 and the second needle part 15) of the medicine transfer needle 20 of the first embodiment, the first vent 14b is connected to the second needle part.
  • the center 15c is formed in the range of 160 ° to 200 ° on the opposite side of the center of the liquid inlet 15b with the center 15c in the 15 axial direction as the center. In FIG.
  • the center of the first vent 14b is disposed at a position of 180 ° on the opposite side of the center of the liquid vent 15b.
  • the second needle portion 15 has a shape in which a sharp end portion is closed.
  • the second needle portion 15 has a liquid passage port 15b on the side surface in the length direction of the second needle portion 15 at a position close to the tip and on the side opposite to the first vent port 14b side.
  • the liquid inlet 15 b is provided on the side surface of the second needle portion 15, and the tip of the second needle portion 15 is closed.
  • produces when inserting the 2nd needle part 15 in the rubber stopper 26 can be suppressed.
  • the coring is a phenomenon in which the rubber stopper 26 is scraped off by the medicine transfer needle 20.
  • the tip of the first needle part 14 has a shape inclined obliquely so that the side having the first vent 14b extends to the second needle part 15 as it approaches the second needle part 15. That is, the distal end of the first needle portion 14 on the first vent 14 b side has a tilt angle ⁇ that extends toward the distal end of the second needle portion 15 as it approaches the second needle portion 15.
  • the inclination angle ⁇ of the tip of the first needle portion 14 with respect to the axial direction 15f of the second needle portion 15 is set to 12.5 ° or more and 20.5 on the side where the first vent 14b is formed. It is designed to be less than °.
  • both the liquid inlet 15 b and the first vent 14 b of the plurality of medicine transfer needles 20 in which the inclination angle ⁇ of the tip of the first needle portion 14 is changed are both medicine containers. It confirmed in the state located inside 25. Specifically, the inventors determine whether or not the air bubbles 30 generated from the first vent port 14b are caught in the liquid flow port 15b when the plunger 21p of the transparent syringe 21 is pulled. It was confirmed by recording and visual observation.
  • FIGS. 5A to 5C are views showing an external structure and a cross section of the drug infusion needle 20 according to the first embodiment of the present invention.
  • FIG. 5A is a front view of the medicine transfer needle 20.
  • FIG. 5B is a cross-sectional view taken along the line 7B-7B of the front view of FIG. 5A.
  • FIG. 5C is a cross-sectional view taken along the line 7C-7C in the front view of FIG. 5A.
  • a liquid passage 15a is formed in the second needle portion 15 along the axial direction 15f.
  • the fluid passage 15a penetrates from the lower needle base 12a to the upper fluid inlet 15b.
  • an air passage 14a is formed in the first needle portion 14 along the axial direction 15f.
  • the air passage 14a penetrates from the lower needle base 12a to the upper first air vent 14b.
  • the center position of the liquid passage 15a is eccentric with respect to the center position of the base portion 16c.
  • the distal end surface 15 g of the needle cover 12 is formed in a tapered shape toward the distal end portion 11 e of the metal needle 11.
  • the drug infusion method of the first embodiment is performed using a drug transfer needle 20.
  • FIG. 6 is a flowchart of a medicine infusion method using the medicine infusion needle 20 according to the first embodiment of the present invention.
  • the medicine transfer needle 20 attached to the syringe 21 is pierced vertically upward with respect to the rubber stopper 26 of the medicine container 25 with the rubber stopper 26 facing downward.
  • the rubber stopper 26 is inserted from the distal end portion 16a of the medicine transfer needle 20 through the intermediate portion 16b to the base portion 16c. That is, in the insertion step S01, both the liquid inlet 15b and the first vent 14b of the drug transfer needle 20 pass through the rubber plug 26 and enter the drug container 25, and the second vent 18 is outside. (See FIG. 7).
  • the plunger 21p of the syringe 21 is pulled to suck the medicine 27 from the medicine container 25 into the medicine transfer needle 20. That is, in the medicine moving step S02, the medicine 27 is moved from the medicine container 25 to the syringe 21 through the medicine infusion needle 20. When the plunger 21p is pulled, the drug 27 in the drug container 25 is drawn into the syringe 21 through the drug transfer needle 20. At this time, in the vent path 14a of the drug transfer needle 20 of the first embodiment, the first vent 14b is in the drug container 25, and the second vent 18 is exposed to the outside of the drug container 25. .
  • the inside and the outside of the medicine container 25 are communicated with each other through the air passage 14 a of the medicine transfer needle 20. Therefore, the same amount of air as that of the medicine 27 drawn into the syringe 21 can be drawn from the outside of the medicine container 25 through the ventilation path 14a of the medicine transfer needle 20 (see FIG. 7). For this reason, even when the above-described pumping operation is not performed, the medicine 27 can be sucked from the medicine container 25 into the syringe 21 through the medicine infusion needle 20.
  • the drug container 25 and the syringe 21 are pulled away in a direction away from each other.
  • the first vent hole 14b is positioned outside the drug container 25 while the liquid inlet 15b remains in the drug container 25 (see FIG. 2).
  • the medicine transfer needle 20 is slightly pulled out from the rubber stopper 26.
  • the preparation of negative pressure adjustment is completed by fixing the position of the medicine container 25 and the position of the syringe 21 relatively in the state of the positional relationship.
  • the plunger 21p of the syringe 21 is pulled.
  • the pressure of the gas inside the drug container 25 is adjusted to a negative pressure via the drug transfer needle 20.
  • the plunger 21p of the syringe 21 is pulled, and when the force that pulls the plunger 21p of the syringe 21 toward the medicine container 25 is generated, the plunger 21p is stopped from being pulled and fixed in that positional relationship. At this time, a sealed space is formed between the drug container 25 and the syringe 21 via the drug transfer needle 20.
  • both the liquid inlet 15b and the first vent 14b enter the medicine container 25, and the second vent 18 is located outside the medicine container 25.
  • the medicine transfer needle 20 attached to the syringe 21 is inserted into the medicine container 25 so as to remain (insertion step S01).
  • the plunger 21p of the syringe 21 is moved to suck or discharge the drug 27 in the drug container 25 or the syringe 21 (drug transfer step S02).
  • the first vent 14b is moved to the outside of the medicine container 25 while leaving the liquid inlet 15b inside the medicine container 25 (negative pressure adjustment preparation step S03), and the plunger 21p is pulled (negative pressure adjustment step S04). .
  • the second needle portion 15 of the medicine transfer needle 20 is completely extracted from the medicine container 25 (withdrawal step S05).
  • a negative pressure adjustment process can be reliably performed, and a drug transfer method that can safely handle the drug 27 and reduce the work load can be realized.
  • an operator such as a pharmacist holds the drug container 25 with one hand so that the rubber stopper 26 is positioned below, and the drug transfer needle 20 attached to the syringe 21 held with the other hand. Is inserted into the rubber plug 26 from below the rubber plug 26 vertically upward. The worker punctures the rubber stopper 26 so that the fluid inlet 15b and the first vent 14b penetrate the center portion 26a of the rubber stopper 26 and enter the medicine container 25.
  • the operator inserts the rubber stopper 26 from the distal end portion 16a of the medicine transfer needle 20 through the intermediate portion 16b to the base portion 16c.
  • the operator can keep the medicine transfer needle 20 and the rubber of the medicine container 25 with the rubber plug 26 facing downward until both the liquid inlet 15b and the first vent 14b are located inside the medicine container 25.
  • the stopper 26 is stabbed.
  • the medicine transfer needle 20 of the first embodiment is pierced until the liquid inlet 15b and the first vent 14b are located in the medicine 27, so that the operator can perform the pumping operation described above. It is possible to perform the suction operation of the medicine 27 from the medicine container 25 without performing it. Therefore, the medicine transfer needle 20 of the first embodiment can reduce the burden of the operator's suction work when sucking the medicine 27 from the medicine container 25.
  • FIG. 7 is a view showing a state in which the suction operation of the medicine 27 in the medicine container 25 is performed using the medicine transfer needle 20 according to the first embodiment of the present invention.
  • FIG. 7 is a cross-sectional view of the drug transfer needle 20 and the drug container 25 in this state.
  • the plunger 21p of the syringe 21 is pulled with the tip of the medicine transfer needle 20 directed vertically upward, and the medicine 27 in the medicine container 25 passes through the medicine transfer needle 20 into the syringe 21. To suck. Then, the medicine 27 is drawn into the liquid passage 15 a of the second needle portion 15 from the liquid passage port 15 b of the medicine infusion needle 20 and flows into the syringe 21. At this time, when the medicine 27 in the medicine container 25 decreases, the gas 29 in the medicine container 25 expands, and the pressure of the gas 29 in the medicine container 25 decreases. However, the inside of the medicine container 25 is connected to the outside through the air passage 14 a of the medicine transfer needle 20.
  • the inside of the medicine container 25 is always substantially equal to the atmospheric pressure.
  • the suction operation of the medicine 27 in the medicine container 25 is performed, the gas 29 inside the medicine container 25 is always equal to the atmospheric pressure.
  • a large amount of force is not required to suck the medicine 27 from the medicine container 25, and the medicine 27 can be continuously sucked from the medicine container 25 by a predetermined amount without performing a pumping operation. . That is, it is possible to realize efficient drug transfer with less burden on the operator.
  • negative pressure adjustment preparation step S03 preparation for negative pressure adjustment inside the drug container 25 is performed.
  • the medicine container 25 and the syringe 21 are pulled away from each other, and the first vent 14b of the medicine transfer needle 20 pierced in the medicine container 25 comes out from the inside of the medicine container 25. In this manner, the medicine transfer needle 20 is moved.
  • the operator can remove the medicine from the medicine container 25 using the position of the liquid inlet 15b of the medicine transfer needle 20 in the medicine container 25 as a mark. Pull out the transfer needle 20.
  • the operator moves the medicine when the liquid inlet 15b of the second needle part 15 is located near the upper surface of the central part 26a of the rubber stopper 26 (the surface on the inner side of the medicine container 25).
  • the pulling out of the injection needle 20 from the rubber stopper 26 is stopped.
  • the operator moves the first ventilation port 14b from the inside of the medicine container 25 to the outside while leaving the fluid inlet 15b of the second needle portion 15 in the medicine container 25, and prepares for the negative pressure adjustment. To complete.
  • the medicine transfer needle 20 is stopped at a position where the liquid inlet 15b is located inside the medicine container 25 and the first vent 14b is removed from the inside of the medicine container 25.
  • the plunger 21p of the syringe 21 is pulled.
  • the medicine 27 in the medicine container 25 flows into the syringe 21 through the medicine transfer needle 20.
  • the gas 29 in the medicine container 25 expands, the pressure of the gas 29 in the medicine container 25 decreases, and the inside of the medicine container 25 becomes a negative pressure.
  • a hole (not shown) is opened in the rubber stopper 26 of the medicine container 25 by inserting the medicine transfusing needle 20 into the rubber stopper 26 up to the base portion 16c in the insertion step S01.
  • a hole (not shown) opened in the rubber plug 26 is opened in the rubber plug 26 even if the base portion 16c of the drug transfer needle 20 is pulled out from the rubber plug 26 in the negative pressure adjustment preparation step S03. (Not shown) and a drug transfer needle 20 may remain. In such a case, a gap (not shown) is generated between the rubber plug 26 and the tip portion 16a.
  • the interval L1 is set to 3 mm or less, so that the intermediate portion having a diameter d2 larger than the diameter d1 of the distal end portion 16a as shown in FIG. 16b remains inserted into the rubber plug 26. Therefore, in the first embodiment, a gap connecting the inside and the outside of the medicine container 25 is closed between the rubber stopper 26 and the medicine transfer needle 20, and the inside of the medicine container 25 can be kept in a negative pressure state. it can. With this configuration, the negative pressure adjustment process can be performed reliably, the medicine 27 does not leak, the medicine 27 can be handled safely, and the medicine infusion needle 20 with a low work load can be realized.
  • the distance L3 is considered in consideration of the elastic deformation of the rubber stopper 26.
  • the interval L3 along the axial direction 15f is set to 7 mm or more.
  • FIG. 8 is a view showing a state in which the rubber stopper 26 is elastically deformed when the negative pressure adjustment processing in the medicine container 25 is performed using the medicine transfer needle 20 according to the first embodiment of the present invention.
  • FIG. 8 is a partial cross-sectional view of the drug transfer needle 20 and the drug container 25 in this state.
  • FIG. 9 is a view showing a state in which the rubber plug 26 is elastically deformed when the negative pressure adjustment process in the drug container is performed using the other drug transfer needle 20.
  • FIG. 9 is a partial cross-sectional view of the drug transfer needle 20 and the drug container 25 in this state.
  • the first vent 14b may be moved to the outside of the medicine container 25 with the liquid passage opening 15b remaining in the medicine container 25.
  • the first vent 14 b is connected to the rubber plug 26 with the liquid inlet 15 b remaining in the drug container 25. Therefore, it is difficult to move to a position where the lid is only partially covered (or outside the medicine container 25). For example, when the fluid inlet 15b comes near the upper surface of the central portion 26a of the rubber plug 26 (the surface on the inner side of the medicine container 25), the medicine transfer needle 20 is used with the fluid inlet 15b as a mark. Suppose you stop pulling out.
  • the medicine infusion needle is used with the first ventilation hole 14b as a mark until the first ventilation hole 14b is completely exposed to a position where the first ventilation hole 14b is partially covered with the rubber stopper 26 (or the outside of the medicine container 25).
  • the liquid inlet 15b is hidden in the rubber stopper 26 due to the depression of the central portion 26a due to the elastic deformation of the rubber stopper 26, and the liquid inlet 15b is blocked by the rubber stopper 26.
  • the distance L3 is set to 7 mm or more which is considered to be more than the maximum value of the thickness of the rubber stopper 26 used in the normal medicine container 25.
  • the above-described medicine transfer method according to the first embodiment does not require a pumping operation in the suction operation of the medicine 27 in the medicine container 25 and can perform a reliable negative pressure adjustment process. Furthermore, in the drug transfer method of the first embodiment, the drug transfer needle 20 can be extracted from the drug container 25 without the drug 27 leaking out of the drug container 25. That is, in the medicine infusion method of the first embodiment, no aerosol is generated. Thereby, in the suction
  • the suction operation of the medicine 27 in the medicine container 25 using the medicine transfer needle 20 has been described.
  • the present invention is not limited to the suction work, and the medicine 27 is transferred from the syringe 21 to the medicine container 25.
  • You may utilize for the discharge operation which sends out.
  • the suction operation is an operation for sucking the medicine 27 from the medicine container 25 to the syringe
  • the discharge work is an operation for discharging the medicine 27 from the syringe 21 to the medicine container 25.
  • the amount of withdrawal of the medicine transfer needle 20 from the medicine container 25 can be accurately controlled.
  • the withdrawal amount is adjusted from information such as the positional relationship between the drug transfer needle 20 and the drug container 25.
  • the first vent 14b can be reliably pulled out from the inside of the medicine container 25 while the liquid passage opening 15b of the second needle portion 15 remains in the medicine container 25. Therefore, the negative pressure adjustment processing of the medicine container 25 can be performed by using the medicine transfer needle 20.
  • FIG. 10 is a schematic front view of the mixing unit 41 in the drug mixing device according to the second embodiment of the present invention.
  • the medicine transfer needle 20 described in the first embodiment is attached to the medicine mixing device, it is possible to perform reliable negative pressure adjustment processing. Pumping operation is not required. Therefore, in the suction operation and the discharge operation of the medicine 27, the medicine 27 does not leak to the outside of the medicine container 25, safety can be ensured, and the work time of the operator can be shortened.
  • the drug mixing device has a region (not shown) that forms a work space for reliably preventing the drug 27 from leaking to the outside of the device, and includes a mixing unit 41 inside the work space.
  • the mixing unit 41 includes a syringe holder 43, a container holder 46, a holder moving mechanism 50, a plunger movable unit 45, a rotational position control device 51, and a mixing unit control device 52.
  • the syringe holder 43 is an example of a syringe holding unit
  • the container holder 46 is an example of a container holding unit.
  • the mixing control device 52 is an example of a control unit.
  • the syringe holder 43 holds the syringe 21 attached with the drug transfer needle 20 vertically upward.
  • the container holder 46 holds the medicine container 25 in an inverted state with the rubber stopper 26 facing vertically downward and the medicine container 25 facing downward.
  • the holder moving mechanism 50 moves the medicine container 25 up and down in the vertical direction by moving the container holder 46 up and down in the vertical direction indicated by the arrow 44.
  • the plunger movable portion 45 includes an electric chuck that detachably holds the plunger, and a drive device that can linearly reciprocate the electric chuck.
  • the plunger movable portion 45 holds the plunger 21 p of the syringe 21 held by the syringe holder 43 and moves the plunger 21 p in the vertical direction of the arrow 44.
  • the rotational position control device 51 is configured by a motor or the like.
  • the rotational position control device 51 has a plurality of positions around the axis of the columnar column 55 for the combination of the syringe 21 attached with the drug infusion needle 20 and the drug container 25 corresponding to the syringe 21 (hereinafter referred to as a mixed set). To control the position.
  • the mixing unit control device 52 controls the drive of the holder moving mechanism 50, the plunger movable unit 45, and the rotational position control device 51 independently.
  • the mixing unit 41 has the container holder 46 disposed in the upper part in the vertical direction and the syringe holder 43 disposed in the lower part in the vertical direction.
  • the drug mixing device of the second embodiment is configured such that the mixing set can be positioned at least at the installation position and the drug transfer position by driving the rotational position control device 51.
  • the installation position is a position for installing the syringe 21 and the drug container 25 in the mixing unit 41
  • the drug transfer position is the above-described drug transfer by driving the holder moving mechanism 50 and the plunger movable unit 45, respectively. This is the position to carry out the pouring method.
  • an insertion step S01, a medicine movement step S02, a negative pressure adjustment preparation step S03, and a negative pressure adjustment step S04 are performed.
  • 2nd Embodiment is not restricted to what implements the chemical
  • the insertion position for performing the insertion step S01, the drug movement position for performing the drug movement step S02, the negative pressure adjustment preparation position for performing the negative pressure adjustment preparation step S03, and the negative pressure adjustment step S04 May be arranged in the order of the negative pressure adjustment positions for performing the respective operations.
  • the plunger movable portion 45 or the moving mechanism 50 is required as appropriate at each position.
  • two or three steps may be performed at one position.
  • an operator opens a carry-in door (not shown) of the medicine mixing device, and attaches the medicine infusion needle 20 to the syringe holder 43 at the installation position.
  • the syringe 21 is installed, and the drug container 25 is installed in the container holder 46.
  • the mixing set is rotationally moved around the columnar column 55 and moved from the installation position to the medicine transfer position.
  • the following drug transfer operation is performed.
  • the holder 46 for holding the medicine container 25 is driven in the vertical direction indicated by the arrow 44 by driving the holder moving mechanism 50 under the control of the mixing unit control device 52.
  • the medicine container 25 is moved downward.
  • the medicine infusion needle 20 is pierced vertically upward from below in the rubber stopper 26 of the medicine container 25.
  • the amount of movement of the container holder 46 is controlled so that both the liquid inlet 15b and the first vent 14b of the drug transfer needle 20 enter the drug container 25, and the second vent 18 is connected to the outside. Sting to remain.
  • the movement amount of the container holder 46 is controlled by storing in advance the necessary movement amount of the container holder 46 in the memory 53 and moving the container holder 46 by the holder moving mechanism 50 by the movement amount acquired from the memory 53. This is done by lowering.
  • the medicine mixing device stops the moving mechanism, and the plunger moving portion 45 is moved vertically downward by the control of the mixing portion control device 52, thereby moving the medicine.
  • S02 is performed. That is, the plunger movable portion 45 is moved vertically downward, the plunger 21p of the syringe 21 is moved downward in the direction of the arrow 44, the drug 27 is sucked into the syringe 21 from the drug container 25, and passed through the drug transfer needle 20 The medicine 27 is moved from the medicine container 25 into the syringe 21. At this time, the pumping operation becomes unnecessary by using the medicine transfer needle 20.
  • the plunger movable unit 45 is again moved vertically downward by being controlled by the mixing unit control device 52.
  • the negative pressure adjustment processing in the medicine container 25 is performed via the medicine transfer needle 20 by controlling the mixing section control device 52 and pulling the plunger 21p by the plunger movable section 45.
  • the plunger moving part 45 is stopped by controlling with the mixing part control device 52, the holder moving mechanism 50 is moved upward, and the medicine transfer needle 20 is completely pulled out from the medicine container 25.
  • the drug container 25 and the drug transfer needle 20 in which the drug transfer needle 20 is completely pulled out from the drug container 25 are taken out from the mixing unit 41 at the installation position or an extraction position provided separately from the installation position. .
  • the drug mixing device can perform not only the suction operation of the drug 27 from the drug container 25 into the syringe 21 but also the discharge operation of the drug 27 from the syringe 21 into the drug container 25.
  • FIG. 10 illustrates a case where a plurality of drug containers 25 and syringes 21 are subjected to a drug transfer process continuously, but the present invention is not limited to this, and one drug container 25 and The present invention can also be applied to a case where a medicine transfer process is performed on one syringe 21. In that case, only the mixed set of one drug container 25 and one syringe 21 in the center of FIG. 10 is used, and the other five drug containers 25 and five syringes 21 in FIG. 10 are deleted. (The three drug containers 25 and the three syringes 21 on the back side are not shown.)
  • the use of the drug transfer needle and drug transfer method of the present invention is useful because it can greatly reduce the burden of mixing drugs by a pharmacist or the like in a hospital or the like.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne une aiguille (20) pour la perfusion de médicament, qui est équipée d'une base d'aiguille (12a), d'une première partie d'aiguille (14) ayant un conduit d'air (14a) dans celle-ci, et une seconde partie d'aiguille (15) qui est plus longue que la première partie d'aiguille (14) et est disposée parallèlement à la première partie d'aiguille (14). Pour la première partie d'aiguille (14), la première ouverture de conduit d'air (14b) qui est une extrémité du conduit d'air (14a) est disposée plus près de la pointe de la seconde partie d'aiguille (15) que la seconde ouverture de conduit d'air (18), qui est l'autre extrémité de celui-ci. Pour la seconde partie d'aiguille (15), une extrémité du conduit de liquide (15a) est reliée à l'intérieur de la base d'aiguille (12a) alors que l'autre extrémité forme l'ouverture de conduit de liquide (15b) de la seconde partie d'aiguille (15). La seconde partie d'aiguille (15) comprend une pointe (16a) ayant l'ouverture de conduit de liquide (15b), une base (16c) qui est reliée à la base d'aiguille (12a) et une partie médiane (16b) qui relie la pointe (16a) à la base (16c). Cette aiguille de perfusion de médicament (20) a une configuration dans laquelle le diamètre de la partie médiane (16b) est plus grand que le diamètre de la pointe (16a) et le diamètre de la partie médiane (16b) est plus petit que le diamètre de la base (16c).
PCT/JP2012/001783 2011-03-31 2012-03-14 Aiguille pour la perfusion de médicament et procédé de perfusion de médicament WO2012132286A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US14/008,808 US9254243B2 (en) 2011-03-31 2012-03-14 Drug transferring needle and drug transferring method
CN2012800163737A CN103458853A (zh) 2011-03-31 2012-03-14 药剂移注针及药剂移注方法
EP12764555.4A EP2692325A1 (fr) 2011-03-31 2012-03-14 Aiguille pour la perfusion de médicament et procédé de perfusion de médicament
JP2013507139A JP5723970B2 (ja) 2011-03-31 2012-03-14 薬剤移注針及び薬剤移注方法

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
JP2011-077622 2011-03-31
JP2011077622 2011-03-31
JP2011253490 2011-11-21
JP2011-253490 2011-11-21

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WO2012132286A1 true WO2012132286A1 (fr) 2012-10-04

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EP (1) EP2692325A1 (fr)
JP (1) JP5723970B2 (fr)
CN (1) CN103458853A (fr)
WO (1) WO2012132286A1 (fr)

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WO2015137155A1 (fr) * 2014-03-12 2015-09-17 株式会社湯山製作所 Aiguille d'injection, injecteur, dispositif de co-injection et procédé de co-injection
WO2023120550A1 (fr) * 2021-12-24 2023-06-29 ニプロ株式会社 Crampon

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US9101717B2 (en) * 2013-03-12 2015-08-11 Carefusion 303, Inc. Non-vented vial access syringe
KR101864650B1 (ko) * 2016-06-03 2018-06-08 (주) 유로사이언스 샘플 채취용 이중바늘 주사기
JP2019530538A (ja) * 2016-10-13 2019-10-24 レプロ−メッド システムズ、インコーポレーテッド 消泡ニードルアセンブリのためのシステムおよび方法
KR102097167B1 (ko) * 2017-10-30 2020-04-10 신항수 일회용 주사기에 사용하는 바늘결합체
CA3015070A1 (fr) * 2018-08-22 2020-02-22 Duoject Medical Systems Inc. Systeme de transfert a liaison facile
CN111374889B (zh) * 2018-12-28 2023-06-20 深圳市卫邦科技有限公司 一种配药装置、配药机器人和配药方法
KR102570478B1 (ko) * 2021-07-30 2023-08-24 이건형 압력상쇄 기능과 미세분말 포집 및, 전량추출 기능을 구비한 니들형 스파이크

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Also Published As

Publication number Publication date
EP2692325A1 (fr) 2014-02-05
CN103458853A (zh) 2013-12-18
US20140230952A1 (en) 2014-08-21
US9254243B2 (en) 2016-02-09
JPWO2012132286A1 (ja) 2014-07-24
JP5723970B2 (ja) 2015-05-27

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